UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016378 |
|---|---|
| Receipt number | R000019018 |
| Scientific Title | The prospective study of halitosis improvement by eradicating Helicobacter pylori. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2022/03/24 19:45:42 |
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Basic information
Public title
The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Acronym
The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Scientific Title
The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Scientific Title:Acronym
The prospective study of halitosis improvement by eradicating Helicobacter pylori.
Region
| Japan |
Condition
Condition
Gstric infection of Helicobacter pylori
Classification by specialty
| Gastroenterology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the halitosis improvement by eradicating Helicobacter pylori
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Halitosis value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eradication of Helicobacter pylori
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of both sexes were selected among those who met all criteria below.
1-1. Patients undergoing upper endoscopy at the clinic
1-2. H. pylori-positive patients without a history of eradication
1-3. Patients who were explained about the rights and responsibilities associated with participation in this study and who provided written consent
1-4. Patients aged 20 years and older at the time of obtaining the informed consent
Key exclusion criteria
2-1. Cases who had presented allergies to drugs contained in the eradication agent
2-2. Patients with a history of upper gastrointestinal tract surgery and pancreatoduodenectomy
2-3. Patients with malignancy detected by upper endoscopy or another test
2-4. Patients requiring upper emergency endoscopy
2-5. Patients with serious underlying disease (respiratory, cardiovascular, or endocrine disease)
2-6. Patients undergoing dialysis
2-7. Patients who were deemed ineligible for this trial by the principal investigator or co-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yui Kudo |
Organization
Kudo clinic
Division name
Kudo clinic
Zip code
Address
Nakadori 1-3-5 Akita city Japan
TEL
018-825-9100
info@kudo-clinic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yui Kudo |
Organization
Kudo clinic
Division name
Kudo clinic
Zip code
Address
Nakadori 1-3-5 Akita city Japan
TEL
018-825-9100
Homepage URL
info@kudo-clinic.com
Sponsor or person
Institute
Kudo clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019018
